JPH02104352A - Method and apparatus for injecting viscous solution in eye in order to remove preretinal and post-retinal membranes - Google Patents

Abstract

PURPOSE: To enable a surgeon not to apply a physical force to an injector containing a material to be injected with his/her hand by designing so that the injector can be received a gas flow filtered through a sterilized filter by air pressure capable of programming selectively. CONSTITUTION: With the package of a sterilized pneumatic hose 34 opened in a sterilized zone, one end of it is connected to a pneumatic output. Next, a sterilized air filter 36 is mounted to the other end of the pneumatic hose 34 within the sterilized zone. A sterilized injector containing a gel to be injected and beforehand packaged is coupled with a segment 60 of the sterilized pneumatic hose connected to the output of the air filter 36. After the coupling, a surgical treatment is carried out. Pressure is set in the continuous mode or one shot mode of the system, and adjusted experimentally according to the conditions of viscosity and operation room temperature by pushing a foot pedal and by observing the gel flow running out of the tip of an injection needle 26.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to the field of intraocular surgery, and in particular to the field of intraocular surgery.
e-retinal membrane) or post-retinal membrane
) relates to a surgical procedure to remove.

(Prior art and its problems) Glue cells IT! (gli.

A cell membrane is formed and sticks to the retina. When the choroid is stimulated by cutting, laser burning, blowing damage, cold/hot damage or other forms of stimulation, fiber cells (f1
Glue cells are extruded from the choroid. Glue cells are glue-like (give-1
ike) and helps repair damage by surrounding the lesion formed by the stimulus. This excretory action of glue cells is often used to attach the detached retina to the choroid. Unfortunately, the mechanisms that control the secretion of fiber and glue cells in the human body are not precisely regulated, so that these cells cannot be released at the appropriate time when enough cells have been excreted to perform their two functions. Unable to stop secretion. Excretion of excess cells often results in the formation of a membrane of cells (mem brane) on the Y4 membrane between the eye lens and the retina. This membrane is
It becomes an optical path obstruction for the Ss film. If the retina is detached, this membrane may form between the retina and the choroid.

The formation of these membranes is associated with proliferative diseases (proliferative diseases).
ferative disease).

The disease often occurs as a postoperative complication of a surgical procedure to reattach a detached retina. One negative effect of this phenomenon is that the glue cells initially form a single-cell-layer membrane between the retina and choroid that covers the retina.
embrane). This film is “
They are attached to various points on the retina by what are sometimes called "nails."

The retina is usually a VELCRO(TM) brand hook-
It is attached to the choroid by a structure similar to and-1 loop-fabric.

When the proliferative disease progresses, there is a problem of spontaneous detachment of the retina. This can happen for the following reasons. That is, the membrane initially forms as a single layer of cells.

Later, this cell becomes multicellular @(
a multiple cell 1 ayer)
Align.

The attachment to the retina at the location of the ``nails'' is very strong. It tends to contract. This contraction places stress on the retina at the location of the "nails", leading to either a hole in the retina or spontaneous detachment of the retina from the choroid.

Another problem with membrane formation is that in conventional techniques for removing such membranes, forces are applied to the retina by the instruments used or through the attachment points of the "nails," causing damage to the structure of the retina. Typically, this occurs by pulling a hole in the retina at a certain "nail" location or by mismanipulating the instrument used to puncture the retina. It ends up.

Also, the process of removing the posterior retinal membrane, that is, the membrane between the retina and the choroid, involves the retinal rods (r.

ds) and cones. The following considerations are made to understand these issues.

In the prior art, surgeons have removed these membranes from the retina using several techniques. One such technique involves holding vertical intraocular scissors with the blades closed and inserting the tip of the scissors between the membrane and the retina.

This is a very delicate process and requires great manual dexterity as the gap between the membrane and the retina is not large.

After the scissors are inserted, the blades are opened very gently to separate the Hi from the retina. This process continues until the nail location is encountered.

Next, horizontal intraocular scissors are inserted into the gap between the membrane and the retina.

Cut the "nail". This process is repeated until the "nails" are found and cut or pulled apart. ``Thus, after the membrane is separated from the retina, the membrane typically
The vitreous is removed using an ablative probe.

Another prior art technique uses an instrument with a hooked fiber optic probe. This hook is very small and is formed at the end of a light pipe. The hook is used to separate the membrane from the retina by inserting its tip between the membrane and the retina and gently pulling the membrane.

A difficulty with these prior art techniques is that damage to the retina can easily occur. One type of damage occurs when the mechanical forces applied to the membrane and transmitted to the retina at the "nail" location are too great. This causes the hole in the retina to be pulled at the position of Nails J.

Additionally, retinal detachment also occurs when the forces applied to the retina through the nails exceed the forces holding the retina to the choroid.

Another type of injury occurs when inadvertent movement of the instrument applies excessive force to the retina while it is held in place by the hook. If the tools are not handled with great skill, holes may be made in the lil membrane. These holes are formed by relatively concentrated forces acting on the retina by the tip of the instrument.

At least one surgeon has reported the use of a manually operated syringe to inject a viscous fluid into the space between the anterior retinal membrane and the retina for lifting the anterior retinal membrane from the retina.

The results of this operation were reportedly of generally similar quality to those obtained by the hook and vertical scissor technique described above. A difficulty with using a manual syringe is that forcing viscous liquid through a very narrow needle channel requires a very large force to be applied to the plunger. This force often causes the surgeon's hand to swing, causing the tip of the syringe to move unexpectedly and uncontrollably within the tiny 1 mm or less gap between the retina and the anterior retinal membrane. This unpredictable movement causes rupture by pulling the nails apart, puncturing the membrane scar.

Therefore, it is possible to gently separate the membrane from the retina without causing spontaneous detachment of the 2w4 membrane, without drawing or punching holes in the 'fA membrane, and thereby not damaging the retina, yet allowing the surgeon's hand to reach the plunger of the syringe. A need has arisen for a method that can be used to cut "nails" without the need to apply physical force.

(Means for Solving the Problems) The viscous material injection device of the present invention is a device for injecting viscous material into the body, and has an air pressure output for generating air pressure having predetermined characteristics at the output section. a pneumatic hose coupled to the pneumatic output, a sterilizing filter for filtering gas flowing through the pneumatic hose, and a syringe having a hollow pointed needle;
The syringe is coupled to the sterile filter to receive a filtered gas stream and has material to be injected within a passageway formed by the syringe piston and the hollow needle.

The syringe also has first and second ends and the first and second ends.
a hollow body with at least two flanges projecting from a location between the ends of the hollow body;

the hollow needle is attached to the second end and in fluid communication with the interior cavity of the hollow body; the filter and the syringe are coupled by a coupler, the coupler being in a second end; 1. Second. and a third section, and the second section has a hollow passage for accommodating a protruding portion of the syringe between the two flanges and the first end, and , the second section has sealing means for forming a pneumatic seal between the protruding portion of the syringe body and the second section, and the second section has a sealing means for forming a pneumatic seal between the protruding portion of the syringe body and the second section; a third section having means for sealing the filtered flange and forming a mechanical connection to the syringe body; and a third section having means for forming a pneumatic coupling for receiving the filtered gas flow from the filter. You may have one.

The syringe may also include a HEALON material within the passageway between the piston and the hollow needle.

The filter may also be an in-line filter placed within the pneumatic hose.

Also, the means for generating air pressure is an EFD.

f East Providence, Rhode
The model 1000XL glue injection device manufactured by 15land may be used.

and a foot-operated control coupled to said means for generating air pressure, said means for generating air pressure having means for applying three selectable air pressure levels to said piston of said syringe, said air pressure levels being coupled to said foot-operated control. It may be a linear function of the ratio to full scale depression.

The glue injection device also includes a footswitch control and means for setting an air pulse time, and wherein a selected programmable air pressure level is applied to the syringe while the footswitch control is actuated. an air pulse executing the first mode and having a selected programmable air pressure peak and a pulse duration set by the duration setting means;

Means may be provided for implementing a second mode in which the air pressure is applied to the syringe upon the first depression of the footswitch and ceases after two selected time intervals have elapsed.

The glue injection device may also include means for generating a selected level of vacuum and applying the selected level of vacuum after application of air pressure in either mode.

It is also a device for injecting a viscous material into the body.

a control transducer, an air pressure peak control, and a time interval control, and when the control switch is actuated, application of a programmable air pressure level set by operation of the air pressure peak control to the output begins.

a first mode in which the application ceases when the control switch is deactivated; and an air pressure pulse having an air pressure peak selected by operation of the air pressure control and a pulse duration set by operation of the duration control. is applied to the output section when the control switch is actuated, and the application is stopped when the time interval set by the one-hour interval control has elapsed.

a pneumatic means for generating air pressure at the output section in any of a plurality of modes including: a pneumatic tube coupled to the output section; a filter pneumatically coupled to the output section via the pneumatic tube; A sterile filter having an output and a sterile syringe pneumatically coupled to the filter output.

The syringe has a passageway formed within the syringe by a sterile piston, the passageway being divided by the piston into at least a first and a second separated passageway, and the syringe has a a sterile hollow needle in fluid communication with a passageway, the filter output being fluidly connected with the second passageway, and the syringe storing a viscous material in the first passageway.

The viscous material may also be HEALON sodium hyaluronate.

The pneumatic means may further include vacuum means for generating a programmable level of vacuum and automatically applying the vacuum to the second passageway of the syringe upon completion of application of pneumatic pressure to the syringe. .

It is also a device for injecting a viscous material into the body.

pneumatic means having a control transducer, the control transducer generating an air pressure at the output that is a linear function of the position of the control transducer; and a pneumatic tube coupled to the output. a sterile filter pneumatically coupled to the output via the pneumatic tube and having a filter output; and a sterile syringe pneumatically coupled to the filter output.

the syringe has a passageway defined within the syringe by a sterile piston, the passageway being obstructed by the piston;
The syringe also has a sterile hollow needle in fluid communication with the first passageway, the filter output is fluidly connected with the second passageway, and the syringe has a viscous material in the first passageway. It's okay to save up.

Also equipped with pneumatic means with maximum pressure control,
the pneumatic means reads the position of the maximum pressure control;
and means for using the maximum pressure set by the position as an upper limit in an interpolation calculation, converting a full scale depression of the control transducer into the pressure set by the maximum pressure control, and generating an air pressure that is a linear function of the position of the control transducer that translates to a pressure substantially proportional to a pressure between atmospheric pressure and the maximum pressure below full scale depression of the control transducer; Also good.

The viscous material injection method of the present invention is a method for injecting viscous material into the body using a glue injection unit with a pressure control for setting the maximum air pressure at the pneumatic output, the method comprising: a hollow needle and a sharp tip; pneumatically coupling a syringe containing a viscous material to be injected to the pneumatic output; applying pneumatic pressure to the syringe and testing the flow rate of the viscous material out of the hollow needle.

adjusting the air pressure until the outflow rate is appropriate; inserting the tip of a cough needle into the body at the location where the viscous material is to be injected; and injecting a sufficient amount of the viscous material. applying the selected air pressure until the air pressure is reached.

It also has a variable pressure control, a variable time control, a mode selection switch to select between continuous mode and one-shot mode, a pressure saw control switch, and a pneumatic output coupled to a syringe with a sharp-tipped needle. Equipped with a section.

A pneumatic unit is used in which the syringe stores the material to be injected. A method for injecting a viscous material into the body,
Observe the rate of flow of the material from the tip of the syringe while injecting the sample outside the body by activating the pressure control switch and applying air pressure to the output, and continue pumping until the desired rate of flow is achieved. setting the pressure by operating a variable pressure control;
Select the one-shot mode by operating the mode selection switch, set the time interval of the air pressure pulses generated during the one-shot mode, and set the number of times the air pressure pulses are generated at the output section. Perform sample injection outside the body by operating the pressure control switch.

operating the variable time control to adjust the pulse time until the appropriate pulse time is obtained; selecting a desired mode by operating the mode selection switch; and when the continuous mode is selected; placing the needle of the syringe at the location where the inflow of the material is to be made and activating the pressure control switch until the desired amount of the material is injected, and then terminating the operation of the pressure control switch; repeating the process at other positions deemed necessary in the body; and if the one-shot mode is selected, placing the needle tip at the position in the body where the injection is to be made and activating the pressure control switch; The method may also include a step of repeating the above steps at other positions as necessary.

The pressure generator also includes a vacuum generator that applies a selected degree of vacuum to the syringe following application of air pressure, and a variable vacuum control.

The step of performing a sample injection outside the body is to apply the variable vacuum control until a sufficient level of vacuum is applied to prevent every last drop of material from spilling from the needle tip following the injection. It may also include a sub-process of operation.

and the location where the material is injected is between the membrane of the eye and the retina necessary to separate the acid membrane from the retina and to separate and destroy all attachment points between the acid membrane and the retina. The injection is carried out in a sufficient number of locations, followed by application of horizontally oriented intraocular scissors through the viscous material to each unbroken attachment point to cut the attachment, followed by removal of the acid film and residual The method may include the step of aspirating the viscous material from the eye.

It also includes a variable pressure control, a single stroke pressure control switch, and a pneumatic output coupled to a syringe with a sharp tip, which syringe stores the material to be injected. A method for injecting a viscous material into the body,
activating the pressure control switch to apply air pressure to the output during sample injection outside the body;
infusion into the body, monitoring the flow rate from the syringe and setting a desired maximum air pressure output pressure by manipulating the variable pressure control until the desired flow rate from the needle tip is obtained; placing the needle tip at the desired injection position, operating the foot-operated pressure control transducer to a selected percentage of full-scale depression, injecting viscous liquid and observing the injection results; The steps may include operating the foot-operated pressure control transducer to obtain sufficient viscous liquid until a result is obtained, and repeating the steps at other locations as necessary.

The location where the material is injected is between the membrane of the eye and the retina, and is necessary to separate the membrane rays from the retina and to separate and destroy all attachment points between the membrane rays and the retina. The injection is made in a sufficient number of locations, followed by application of horizontally oriented intraocular scissors through the viscous material to each unbroken attachment point to cut the attachment, followed by the membrane and remaining attachment points. The method may also include the step of aspirating the viscous material from the eye.

In accordance with the teachings of the present invention, an apparatus and method for injecting viscous fluid into the membrane-retinal gap is provided.

This viscous fluid forms pockets over the "nail" attachment in the gap between the membrane and the retina. These pockets of viscous fluid exert extended pressure (dif) on the membrane and retina, and once these structures are separated, horizontally oriented intraocular scissors are passed through the viscous fluid and inserted into the gap between the membrane and retina. can be inserted into the These scissors are inserted up to the "Nails J" position.

The "nails" can be cut, thereby separating the membrane from the retina. Simply injecting a viscous liquid can cause the nails to come undone. This process is of a very diffuse nature and the pressure exerted on the retina is 1
It is done without damaging the m-membrane because it is not localized to one small area and reduces stresses that would otherwise exceed the strength of the retina. In a preferred embodiment, self-adhering prop6
rties) is used as the injection fluid. Several brands of liquids have been found suitable for practicing the present invention. One such liquid is Ph
HEALON (trademark) sold by armacia
It is sodium hyaluronate. Other liquids that can be used for the practice of this invention are described by Johnson and Jh
AMVISC™ sodium hyaluronate sold by Onson. These liquids can be used in a commercially available glue injection device (glue 1njectin).
It is injected using a modified version of the device. In a preferred embodiment, Rhode Island
Is 1and) EFD of East Pr
model 100 manufactured by evidence
A 0 XL glue injection device is used.

The glue injection device is coupled to a source of pressurized air and includes a pressure regulator. This device uses a henchuri and pressurized air to create a vacuum. The glue injection device includes a foot switch and a pressurized air output connected to a syringe containing a viscous liquid. The air pressure at the pressurized air output is controlled by manipulating the internal pressure regulator controls. The pressure is set between zero and 40 bonds per square inch.

This device has two modes. The first mode is continuous mode and the second mode is "one shot" mode. In the first mode, when the footswitch is depressed, the pressure increases to the pressure set by the pressure regulator and remains at that pressure for as long as the footswitch is depressed. When the foot switch is released, the output pneumatic tube vents to the atmosphere.
) or a vacuum pressure is applied to prevent fluid from leaking out of the needle connected to the pneumatic output.

The level of vacuum applied at this stage is controlled by other controls on the front panel of the unit. In the second mode, a pressure pulse with a variable duration is applied to the output tube. The pulse begins when the footswitch is pressed and stops after a predetermined interval.

The duration of the pulse is set by a timer control that is manually operated from the front panel of the unit. The standard glue injection device of the system is replaced by a sterile HEALON™ sodium hyaluronate or other viscous liquid injection syringe to which a pneumatic output tube is connected from the pressure regulation unit. a threaded adapter with an O-ring to mechanically couple the syringe and the pneumatic output tube to form a pressure seal;
A threaded bezel ring paired with
A special sealing adapter with a bezel ring is used. The bezel ring.

It fits around the syringe and closes its flange.

The plunger or piston inside the injection syringe is pressure-transmitted from the pressure regulating unit through the special adapter and pneumatic hose mentioned above. Air pressure is then applied by a pressure regulating unit coupled to the piston, causing the piston to move downward within the syringe. This force is applied to the hollow needle attached to the syringe cylinder.
Push the viscous liquid out of the syringe through the tip of the lowneedle.

Pneumatic line (pne) between the pressure adjustment unit and the syringe
A filter is provided in the umatic 1ine). This filter removes the pressure air flowing to the syringe from any external objects of particular size or larger.
ign bodies).

Alcon Surgical Division
of Alcon Laborator
ies, Inc. of Fort
Worth.

Texas and San Leand
ro.

A third mode, called linear continuous mode, is achieved by using the functionality of the MVS™ intraocular surgery console from California. In this mode, the syringe containing the viscous liquid to be injected is
S is coupled to the console's pressure output boat and the console is placed in proportional cutting scissors mode. In this mode, the pressure appearing at the pneumatic output of the MVS console is approximately a linear function of the position of the foot-operated control.

The maximum pressure when the foot pedal is depressed is set by the user using a front panel control. MVS
A microprocessor located in the console interpolates pressure values between the maximum and zero pressures set by the front panel controls based on the percentage of full scale depression of the foot operated controls.

A method of using the above-described device to perform a surgical procedure to remove anterior or posterior retinal membranes is as follows.

First, a syringe is attached to the pressure adjustment unit. The pressure regulating unit is located outside the sterile field and the sterile syringe is attached to the pneumatic tube after it has been placed within the sterile field. The desired pressure is set by operating the appropriate controls on the front panel. this is,
It is executed regardless of whether continuous mode or one-shot mode is selected.

One shot mode or continuous mode is then selected by operating the appropriate switch on the front panel of the pressure regulating unit. In one-shot mode, the desired pulse duration is set by operating the appropriate controls on the front panel. By operating the appropriate controls on the front panel of the pressure regulation unit, the level of vacuum applied to the pressure output tube after the pressure pulse is set.

In continuous mode, both pressure and vacuum levels.

It is set in the same way. In either mode, pressure and vacuum levels are applied outside the eye in a sterile field to obtain the injection rate required for the prevailing conditions, such as temperature and retinal health or intensity. set by experimental injections performed at The surgeon has already assessed the strength of the retina from the previous surgery.

Next, the needle tip is inserted into the gap between the retina and the anterior or posterior retinal membrane. A footswitch is then depressed to inject HE AL ON sodium hyaluronate into the space between the anterior or posterior retinal membrane and the retina. This can be done in any of the three modes mentioned above. Thus, the anterior y1 membrane or the posterior retinal membrane is lifted and pushed away from the retina by injection of viscous fluid. The surgeon decides to stop the injection when it appears that too much stress is likely to be applied to the retina through the nail attachment. This injection process is repeated at multiple locations to destroy or separate any "nails" or connection points between the anterior or posterior retinal membranes and the retina itself. The "nails" that were not destroyed by the injection process itself are then cut using horizontal intraocular scissors.

When all connection points have been severed, the membrane is typically removed using a vitrectomy probe or other suction device. The HEALON sodium hyaluronate or other viscous material remaining in the eye is then removed with a vitrectomy probe or other suction device.

(The following is a margin) (Example) FIG. 1 is an anatomical cross-sectional view of the eye. Parts of particular interest to the present invention are the meshwork, designated 10, and the choroid, designated 12. The retina may detach from the choroid for a variety of reasons. When this occurs, treatment is performed to reattach the retina to the choroid.

Usually this is done by injuring the choroid using any of several possible methods.

Laser energy is often applied through the sclera 14 and choroid 12 to create the wound. Cutting, heat or other mechanical stimuli can also be used to create the wound. Glue cells sprout from choroidal wounds. These glue cells grow out of choroidal scars and, because of their glue-like properties, tend to reattach the retina to the choroid. but,
Because the body does not have sufficient control over the growth of these glue cells, the glue cells often form a membranous single cell layer between the retina and the lens 16. A portion of such an anterior retinal membrane is indicated at 18. These anterior retinal membranes tend to attach themselves to the retina at arbitrary intervals. Such attachment points or "nails" are indicated using symbols at 20 and 22. ``There are several problems associated with anterior retinal membranes as complications after surgery. First, this membrane blocks the path of light through the vitreous to the retina, thus disrupting vision. The anterior retinal membrane then tends to reorganize itself from a single cell layer to a bilayer cell layer.

A portion of such a reconstituted membrane is shown at 24.

This latter phenomenon is problematic because the anterior retinal membrane atrophies during its remodeling process, placing stress on the retina through the nail connections. This stress causes the retina to wrinkle, tear, or detach, which is extremely undesirable. The solution to this problem is to remove the anterior retinal membrane.

As mentioned in the description of the prior art, the membrane after one surgery is not necessarily in front of the retina.

Sometimes it is formed between the '414 membrane and the choroid. However, the posterior retinal membrane also attaches itself to the M4 membrane at arbitrarily spaced nail attachment points and rearranges itself from a single cell layer to multiple cell layers, resulting in the above problems. Similar observations apply.

A good way to remove the membrane is to place a HEALO between the membrane and the retina.
Applicants have found that injecting a sticky self-adhesive liquid such as N-gel.

This is done by inserting a needle into the gap between the membrane and the retina and pouring a sticky gel into the gap.

FIG. 1 shows such a needle 26 in position to start injecting liquid.
shows.

FIG. 2 shows the result of the injection of adhesive gel into the gap between the membrane and the retina 10, indicated at 28 and 30, by the injection process. Bubbles of injection gel are formed. This bubble lifts the membrane 24 away from the retina 10 by applying widespread pressure to both the retina and the membrane. This "wide range" is meant to be wide compared to the stresses created on the retina by tools used in the prior art. Removing the membrane (Previous methods used mechanical hooks to hook the membrane and lift it away from the retina. If the hook is not manipulated properly, the tip of the hook will impact a small portion of the retina. This creates a localized force that increases stress levels on the retina beyond what this delicate structure can easily withstand. The spreading nature of the pressure applied by the injected gel according to the teachings of the present invention
0 and the stress tends to be dispersed over a wide range of the surface of the membrane 24. Because the force exerted by the injected gel is spread over a large area, the stress level at a particular point on the retina will increase.

This results in lower stress levels than those applied to the retina by conventional methods. Improper manipulation of the tools used in prior art methods can lead to retinal tears.

There were often holes. By using the teachings of the present invention, the possibility of damage to the retina is substantially reduced because the need for contacting the retina with rigid instruments is eliminated.

When the gel injection is complete and the structure of the entire area covered by the membrane is as shown in FIG. 2, the membrane is removed. Nail attachments tend to detach the retina from the choroid or puncture the retina at the point of attachment.

The membrane cannot be pulled away from the retina simply using a hook device. Therefore, it is necessary to cut this nail attachment using horizontally oriented intraocular scissors. this is,
This is done by moving the tip of intraocular scissors through the injected gel to the nail position and cutting the nail. Although this sequence of actions is not shown in FIG. 2, those skilled in the art will understand how this is done.

Figure 3 shows the system used to inject gel 28 which lifts the membrane away from the retina. The system is equipped with a pneumatic and vacuum control unit 32, hereinafter referred to as the control unit. System unit 32 is located in Rhode Island East Province.
(model number 1000XL) manufactured by EFD (Model Number 1000XL). Control unit 32 is coupled to a pneumatic source by a connector (not shown) on the back of the unit. In some embodiments, the control unit is coupled to a vacuum source by a vacuum input (not shown) on the unit l-i side. What is the purpose of the control unit 32?

3. Controlling the amount of air pressure applied to pneumatic output 34. This pneumatic output is.

It is coupled to a syringe 38 through an air filter 36 by a pneumatic hose 34a. The syringe has a piston that is driven by air pressure toward the injection needle 26.

This forces any liquid contained within the syringe cavity 42 out of the tip of the needle 26. Two types of syringes are commonly used for this purpose. These two differ depending on the type of flange attached to the syringe body. One of these is a syringe, such as the one shown in FIG.

The syringe has two ear-shaped portions extending on either side of the barrel.

Another type of syringe has a polygonal, annular or nearly annular flange surrounding a cylindrical portion. These two types of syringes require different types of adapters when connecting to pneumatic hoses.

Air filter 36 serves to filter any fine particles from the air flow within pneumatic tube 36 .

This air filter must be sterile and disposable or autoclavable. Syringe 38. Needle 26. and piston 40 must also be autoclavable or sterile and disposable.

The control unit has an air pressure gauge 44 that monitors the level of air pressure being applied to the syringe 38. The amount of pressurization is controlled by a front panel knob 46. It is controlled by the air pressure regulator in the control unit. control unit 3
2 has a power on/off switch 48 and a mode control switch 50. This mode control switch switches the control unit between steady mode and one shot mode. In steady mode, the air pressure level set by operation of the air pressure regulator control knob 46 is applied to the air pressure output 34 from the time the foot pedal control 52 is pressed until the time the foot pedal control 52 is released.

In "one shot" mode.

The amount of air pressure each pulse is applied to air pressure output 34 is set by operation of air pressure regulator control knob 46 .

The duration of this air pulse is controlled by operation of time control knob 54. A pneumatic pulse is generated by the control unit when the foot pedal 52 is pressed. Pneumatic pulse is generated by foot pedal 5
2 automatically ends at the end of the time interval set by the time control knob 54, regardless of when it is released.

For low viscosity liquids, it is advantageous to apply a vacuum to the pneumatic output 34 at the end of the pneumatic cycle. This vacuum pulls the piston 40 away from the needle 26,
Liquid is thus sucked back into the needle 26. This prevents the last drop of liquid stuck to the tip of the needle 26 from falling off the needle tip at an inappropriate time or in an unintended location. The level of vacuum applied to pneumatic output 34 is controlled by a vacuum control knob 56 on the front panel of the control unit. The vacuum level is adjusted using a vacuum pressure gauge 58 as a guide. The level of vacuum set by vacuum control knob 56 is automatically applied to output 34 at the end of each air pulse or after application of air pressure. If vacuum suction is not required.

Vacuum control knob 56 is operated such that zero vacuum pressure is indicated on vacuum pressure gauge 58. The vacuum is.

It is generated in the control unit 32 using a venturi that changes the air pressure of the escaping air to sub-atmospheric pressure.

The air pressure of the output line 34 is 1 to 100 ps i
can be set to a desired value. Typical operating pressures are on the order of 30-40 ps i depending on temperature and viscosity.

In operation, the control unit 32 is located outside the sterile area. The package of sterile pneumatic hose 34 is then opened in this sterile area.

One end thereof is connected to a pneumatic output.

A sterile air filter 36 is then attached to the other end of the pneumatic hose 34 within the sterile area. Contains gel to be injected. 1 pre-packaged sterile syringe
It is then cabled to a segment of sterile pneumatic hose connected to the output of air filter 36. In a preferred embodiment.

The cavity 42 of the syringe 38 contains HEALON gel.

More detailed construction of the syringe 38 and the adapter for coupling the syringe to the pneumatic hose segment 60 will be described below.

Once the syringe is attached to the pneumatic hose segment 60, the surgical procedure is performed using the following procedure. First, the desired air pressure peak is set using the air pressure regulator control knob 46. It is desirable that the gel injection flow rate be very low to prevent sudden excessive amounts of pressure being applied to the retina and membranes. Therefore, the maximum pressure must be set below 30-40 psi. The pressure is.

Place the system in continuous mode or one-shot mode,
The viscosity is experimentally adjusted to the current viscosity and operating room temperature conditions by pressing the foot pedal and observing the flow rate of gel exiting the tip of the injection needle 26. If more flow is required, the pressure is increased by operating the air pressure regulator control knob 46. When a lower flow rate is desired, a lower air pressure is set using the air pressure regulator control knob 46. The desired vacuum level is also set depending on the current viscosity and temperature conditions when vacuum is required.

The appropriate mode is then set. If one shot mode is selected, the duration of the air pulse is set using time control knob 54. The aforementioned step of setting the desired injection volume is not only based on the current temperature and viscosity conditions, but also on the health or strength of the m-membrane. This latter information.

The diameter is usually determined based on previous surgical procedures. This surgery irritated the choroid and produced a membrane.

The tip of the needle 26 is then placed in the gap between the retina and the membrane. Fluid from cavity 42 is then injected while the surgeon observes the expansion of the membrane. The injection is discontinued if too much stress appears to be being applied to the retina through the nail junction. This injection process.

This is done in a sufficient number of locations to completely break and/or separate all nail connections between the membrane and the retina. Care is taken to avoid puncturing the retina or detaching it from the choroid by applying excessive force to the retina through the nail. The unbreakable nail is then cut using horizontally oriented intraocular scissors. Finally, the membrane is removed using a vitreous cutting probe or other suction instrument. and the injected gel is removed using a vitrification ablation probe or other suction device.

FIG. 4 is an exploded view of the syringe. The syringe has flange 6
2 and a syringe holder 64.

Syringe holder 64 has a lock-in mechanism that engages flange 62 . In the embodiment shown in FIG.
The flange 62 is bayonetly engaged with the lock-in mechanism 66, as shown generally at 68. Syringe body 38 has a piston 40 shown as in FIG. With this piston, the syringe body 39
An air and liquid tight seal is formed on the inner wall of the Syringe body 38 terminates in needle 26 (not shown) which is protected by cover/handle 70. This cover/handle has a protrusion 72 at its tip, and can also be screwed onto the piston 40 to manually operate the piston.

The syringe shown in FIG. 4, with the exception of the syringe holder 64, is an IIEALON-containing syringe sold by the manufacturer of HEALON gel. Syringe holder 64
is a special adapter configured to allow the piston 40 to be operated by air pressure and vacuum from the input line 60. Therefore, the purpose of the cover 70 is.

It is simply to protect the injection needle 26 (not shown) and maintain its sterility.

Syringe holder 64 engages syringe body 38 and a mechanical connection as well as a pneumatic seal is formed between syringe body 38 and pneumatic hose 60 . For this purpose, the syringe holder 64
There is an internal passageway 74 which is in fluid communication with the pneumatic tube 60. When the syringe holder 64 engages the syringe body, the syringe body extension 76 of the flange 62 on the syringe holder side.

When the flange 62 is engaged with the lock-in mechanism 66, it is slid into the passageway 74. O-ring seal in passage 74 (
(not shown) is in close contact with the side wall of the portion 76 of the syringe body;
A pneumatic seal is formed.

Details of the structure of the syringe holder are shown in FIG.

The syringe holder includes a body 64 having a lock-in mechanism 66 formed therein, and is typically formed by casting or injection molding. The body has an internal passageway 74 which is in fluid communication with a second passageway 77 within the pneumatic tube retaining projection 78 . This protrusion 78.

It has ribs 80 for engaging flexible pneumatic tubing to form a mechanically sound bond and pneumatic seal. A groove 82 is formed in the internal cavity 74 in which an O-ring is placed.

This O-ring must be made of silicone or other flexible and autoclavable material.

In the embodiment of FIG. 5, the outer edge of the lock-in mechanism 66 is threaded. These nejamas are the 6th A.
It is engaged with similar threads on the inside of the bezel ring 84 shown in the Figures and 6B. 6A and 6B illustrate a bezel ring that engages the flange 62 of FIG. 4 as an alternative to the bayonet lock-in mechanism shown in FIG. FIG. 6A is a plan view of this bezel ring, and FIG. 6B is a sectional view of the ring taken along line 6B-6B' in FIG. 6A. The bezel ring includes a body 84 having a threaded portion 86 and an aperture 88. Aperture 88 has flange 62 at surface 90 shown in FIG. 6B.
It is slid through the body 38 of the syringe in FIG. 4 until it rests against the body 38 of the syringe. The syringe body portion 76 passes through the aperture 88 in the -X direction of FIG. 6B. Indicated by A in FIG. 6B,
The inner diameter of the threaded portion 86 is as follows.

It closely fits the outer diameter of the lock-in portion 66 of the syringe holder 64. Lock-in portion 66 is then threaded into threaded portion 86 of the bezel ring in FIG. 6B.

A mechanical connection is formed between the syringe holder 64 and the syringe body 38. The O-ring of groove 82 then seals against the wall of portion 76 of the syringe body, thereby forming a pneumatic seal. This O-ring is shown at 92 in FIG.

7A and 7B illustrate a preferred embodiment of a syringe holder 64 having a bayonet type lock-in mechanism 66. FIG. 7A shows an end view of the syringe looking down the centerline, and FIG. 7B is a cross-sectional view of the syringe along line 7B-7B' of FIG. 7A. Similar to the syringe holder shown in FIG. 5, the syringe holder has an internal passageway 92 formed with a groove 94 in which a flexible, autoclavable O-ring is placed. This O-ring fits tightly against the side wall of portion 76 of the syringe barrel of FIG. 4 to form a pneumatic seal. The syringe holder shown in FIGS. 7A and 7B and FIGS. 5, 6A, and 6B
The only difference from the syringe holder shown in the figures is essentially the lock-in mechanism.

This lock-in mechanism 66 has a pair of L-shaped grooves 96 and 98.
4, which is best seen in FIG. These grooves engage the two protruding tips of flange 62.

To operate the lock-in mechanism, portion 7 of the syringe barrel
6 is inserted into passageway 92 and tightly contacts the OIJ song, forming a pneumatic seal. Through this process.

The protruding portion of the flange 62 is pushed into the L-shaped groove.

Note that when the flange 62 is in close contact with the wall 100 of FIG. 7B.

The syringe 38 is rotated approximately one-eighth of a turn to the right so that the flange 62 is twisted within the lock-in 66 to lock the syringe barrel in place in the syringe holder lock-in mechanism shown at 68 in FIG. 4.

Figures 8A and 8B illustrate one other type of adapter.

This connects the syringe body to the pneumatic hose 6 when a syringe with a polygonal, annular or approximately annular flange is used.
This is for connecting to 0. This adapter includes a threaded bezel ring 102 that engages an annular or polygonal flange 104 attached to a syringe body 106.
＋i# is getting. A plug 108 having a threaded shoulder 110 and a prong member 112 is inserted into the syringe cavity. The plug 108 has a pneumatic passage 114 that connects the pneumatic hose 60 (not shown).
The syringe cavity is coupled to a pneumatic connector 116 that has a shoulder that forms an airtight seal with the syringe cavity. The protruding portion 112 of the plug has a groove in which a Q IJ song of flexible, autoclavable material is placed. The materials described above form an airtight seal between the plug and the inner wall of the syringe body 106.

(Left space below) Figures 8A and 8B show two block diadems of the MvsIII surgical instrument used in the proportional cutting scissors mode for performing the continuous linear pressure injection mode of the present invention. CPU 130 serves as the central controller for the MVS system and connects data bus 132 . address bus 134.
and control the various units coupled by control bus 136. In a preferred embodiment, the CPU
130 is an Intel 8031 microprocessor. A program for controlling the operation of a microprocessor and all units coupled to carry out the process of the present invention is contained in U.S. Pat. No. 4,768,506, which is incorporated herein. Two variations or prototypes of the MVS system with proportional cutting scissor drive modes are sufficient for the purpose of carrying out the present invention. The software that drives the MVS system is PROM (programma
ble read-only memory) 13B
FROM 138 is for microprocessor 130 to access instructions for executing the processes of the present invention.

Generally, the microprocessor 130 interfaces with foot actuated controls and various front panel switches and controls, vacuum generation systems, pneumatic systems, and the like.

Solenoid operated valves, relays and displays.

and indicators to carry out the processes carried out in the various modes in which this machine operates. User interface is through front panel control switches, potentiometers, footswitches, and a display.

The microprocessor 130 has two D/A (digi
tal-to-analog) converters 140 and 1
Connected to 42.

Control the pneumatic and vacuum systems respectively. Details of the operation of these systems will be described below.

The A/D (analog-to-digital) converter 144 is.

Analog data from various sensors and control devices indicating the state the machine is under is converted into digital data that can be read by a microprocessor. In order to control the vacuum and pneumatic systems, certain information must be provided to the microprocessor 130 by the user.

For example, in irrigation and suction mode, vitrectomy mode, and cutting mode, 9 to aspirate tissue, irrigation fluid, and body fluids from the area being operated on.

This system provides vacuum to the hand tools used by the surgeon. There are two user inputs to control this vacuum generation process. One is the maximum vacuum the surgeon desires for the machine, and the other is the vacuum desired at a particular point in time. The maximum vacuum level is set by the surgeon via a potentiometer or other control 146 on the front panel. □ The actual vacuum or the vacuum desired by the surgeon at a particular time is read from a foot switch 148, and the surgeon signals his desired higher or lower vacuum by raising or lowering the foot switch 148. The foot switch position sensor also detects the blade enclosure (b) in the multi-cutting scissor drive mode.
lade closure) frequency, that is, the cutting speed. Details of how the footswitch is read will be given below in the description of the vacuum control system.

In the vitrectomy mode, a cutting probe of construction well known in the art is pneumatically driven by pulses of compressed air. The frequency of these pulses is controlled by the cutting speed adjustment control section 150. The address provided by the microprocessor to the A/D converter 144 tells which of these analog inputs connected to the A/D converter's multichannel inputs have been selected and converted to a digital number.

The display 152 is an LED (LED) in a preferred embodiment.
A display of any type may be used by the microprocessor 130 to display a bar graph of the cutting speed in the vitrectomy mode.

Front panel control section and sensor interface 1
54 is coupled by a bus 156 to several switches and an alphanumeric display 158.

Alphanumeric display 158 indicates the mode in which the machine is currently operating, as determined by microprocessor 130.
It is used to display various items of information such as actual vacuum, maximum desired vacuum, and other messages. Several mode select switches 160 on the front panel are used by the surgeon to select which of several modes the machine should operate in.

There are five main modes in which this machine operates, along with irrigation and suction modes with three sub-modes. Mode selection is accomplished by three toggle switches as in the preferred embodiment, by a rotary switch, or by separate switches for each mode. The details of how this mode selection is performed will be clear to those skilled in the art.

Cassette eject switch 162 is used by the surgeon when cassettes (not shown) must be removed all at once. When this switch is pressed, microprocessor 130 causes a solenoid-operated valve to disengage and remove the cassette from the front panel chamber. A microswitch type sensor 164 near the cassette is mounted within the cassette chamber to change the state of the switch when a new cassette is pushed into the chamber.

As seen in connection with the discussion of other figures, the cassette has two bottles for storing the aspirated substance.

The substance is aspirated until the small bottle is full.

The fullness of the small bottles is detected by the microprocessor 130 through the small bottle level sensor 166. This sensor, in the preferred embodiment, is a pair of wires that protrude from the top of the small bottle. When the liquid approaches the top of the bottle, an electric current flows between these wires. When this current is sensed by the microprocessor, the microprocessor knows that the small bottle is full and starts transferring to the large bottle.

Also vacuum line moisture sensor 168. It is provided to protect this machine in the event that the fluid transfer mechanism described above fails.

The input air pressure switch 170 is activated if the input air pressure is

For machine operation the receiver is put in to alert the system when it falls below a certain minimum air pressure.

Monitor compressed air entering the system.

The buffer unit and relay 172 are a known fragmenter handpiece.
) provides on-off control. a cutting handpiece;
The presence of a cable coupling this system to this device allows microprocessor 130 to connect buffer 1 to the cutting handpiece outside the serial transport data port.
is detected by sending a signal through 31.

If a cutting handpiece is present, this signal returns on this cable through buffer 133 to the receive data port of microprocessor 130. Relay unit 172 provides power to the cutting handpiece. This unit 172 basically consists of a latch and lay driver.

It is addressed via RAM and I10 port unit 174.

Additionally, this unit 174 has 110 ports.

This is addressed by the microprocessor when it wants to write or read data to a particular peripheral. One of these I10 ports is coupled to buffer and disconnect control relay unit 72. The footswitch's microswitch 174, which controls the cutting operation, is coupled to the microprocessor's pinches 4 and 5 via a buffer 178. When the microprocessor throws this microswitch and determines that a disconnect is desired, it addresses a particular I10 port coupled to the buffer and disconnect control relay unit 172 and sends the data to the latches and buffers of this unit 172. Write, indicating that disconnection is desired. This data then controls the ray driver circuitry within unit 174 which is coupled to bus 180 and which activates the rays. This bus provides signals to the cutting transducer handpiece where cutting is desired. Electricity is bus 1
80, but may be provided in some embodiments.

Microprocessor 130 addresses nine different peripheral units using address bus 134 and decoder 1B2. When a particular unit is addressed for reading or writing, that unit's address is placed on address bus 134 and decoder 182 decodes the address. Decoder 182 then activates the chip select line connected to the particular peripheral's chip enable input. The unit then activates its data and control ports from tristate, thereby reading data from the microprocessor 130 on the data bus 132 or writing data to the microprocessor 130 on the data bus 132, and , control bus 136
The state of the various control signals above can be read.

Additionally, the I10 boats in the RAM and the I10 units 174 are individually connected to nine pneumatic control valves 183 which are solenoid operated by a bus 184 and a solenoid driver 186. These solenoid operated valves 1
83 gates compressed air on input pneumatic line 188 to one of a number of pneumatic pistons 189, 190, 191, 192° and 193. These pneumatic pistons perform various fluid valving and latching functions. These features will be more fully explained in connection with the discussion of pneumatic control systems below. Each solenoid operated valve is connected to a RAM and I10 boat unit 174. One may be individually operated by microprocessor 130 via bus 184 and driver 186. Pressure regulator 195 ensures that the input air pressure on line 188 is stable even if the air pressure on line 192 fluctuates.

Vacuum The MVS system has a vacuum mode for surgical suction. Some of these modes are:

It requires the generation of a vacuum to be transmitted to the hand tools and suction of the cut sacrificial and irrigation fluid from the area where the surgeon is working. As shown in FIG. 8B, the surgeon controls the desired vacuum level by means of a footswitch position sensor 148. This is microprocessor 130
read by. Microprocessor 130 addresses A/D converter 144 and reads words of its digital output. This word is for the footswitch position sensor.

A digital representation of the displacement relative to its termination.

That is, it is a percentage of the full scale depression of the foot pedal. microprocessor 130
ii reads the setting of the high vacuum control 146 and converts the desired analog input to a digital value by addressing the A/D converter 144 and selecting the highest vacuum control. As can be seen in Figure 8A, the A/D converter is connected to several analog inputs.

These inputs include a vacuum sensor 149 on line 151, a footswitch position sensor 148 on line 153. Maximum vacuum control 146 on line 155. and line 15
It comes from the cutting speed adjustment control section 150 above 7. The particular input selected depends on the state of three bits on the address bus.

Once the maximum vacuum control 146 and footswitch piston sensor 148 are read, the actual vacuum desired is derived. This is accomplished by the microprocessor multiplying the maximum vacuum setting by a fraction or percentage of the total possible displacement of the footswitch. The resulting digital values are addressed using decoder 182 and D/A converter 142.
By writing data to the input latch of the 0/A converter 142. The footswitch position sensor 148 and the maximum vacuum control 146 are examined nine cycles by an interwoven service routine that occurs whenever a timer within the microprocessor times out. The digital word of the desired vacuum thus sent to the D/A converter 142 during which time the footswitch position changes.

In the preferred embodiment, the vacuum control is changed each time the vacuum control interoperates.

This interloved appears 100 times per second.

The calculated desired vacuum digital value is first converted into an analog signal, which signal is transferred via line 159 to the non-inverting input of differential amplifier 161. This differential amplifier has an inverting input coupled to the actual vacuum feedback signal on line 151 from vacuum sensor 149. This sensor is pneumatically coupled to the throat of venturi 165 by vacuum line 163. The venturi acts to convert the air flowing under compression to near atmospheric pressure.The pressurized air input or venturi 165
The main air channel of is coupled to an electrically actuated linear valve 169 by a pneumatic line 167.

Such valves are known in the art.

Manufactured by Preciskon Dynamic Inc. as Model N [LA2011-351. Linear electrically actuated valves are also present in the linear pressure actuated control valve system 249. This system is discussed in more detail below.

CAR' SYSTEM Referring again to FIGS. 8A and 8B and FIG. 9, a block diagram of the pneumatic control system is shown. This system has several modes in which pressure greater than atmospheric pressure is supplied and controlled by the system and directed to hand tools used by the surgeon, such as scissors or syringes. For example, in the scissor proportional cutting mode, an air pressure proportional to the position of the bipedally operated control is applied to the pneumatically driven scissors or, as in the case of the present invention, for injecting viscous fluids. I was hit by a syringe.

The pneumatic control system is somewhat similar to the vacuum control system in which the switch 160 is checked in that the 5 operator required mode is that the foot actuated controls are read. After the necessary data has been collected, a calculation of the cutting speed or desired pressure is made and the microprocessor writes a digital word to the D/A converter 140 of FIG. 8A.

This digital value is converted to an analog signal on line 223 which is coupled to the non-inverting input of differential amplifier 225. The inverting input of differential amplifier 225 is coupled to the actual pressure signal on line 227. This signal is generated by a pressure sensor 229 that has a pneumatic input coupled to a pneumatic line 231 that is connected to a pneumatically driven hand scissor.
or in one case of the present invention, coupled to a syringe containing the viscous fluid to be injected. Differential amplifier 225 is connected to line 2
The actual pressure signal on line 227 is subtracted from the desired pressure signal on line 23 to generate an error signal on line 233.

As shown in FIG. 9, this error signal is applied to the non-inverting input of another differential amplifier 135;
is similar in function to amplifier 75.

The output of this amplifier is coupled to the base of a transistor 237 having an emitter feedback resistor 128. The emitter node is connected to differential amplifier 135 by line 241.
is coupled to the inverting input of amplifier 135 and transistor 237 . The combination of and resistor 128 converts the error voltage on line 233 into a current flowing through coil 239 of electrically actuated linear valve 244 in a manner similar to that in a vacuum control system. This current acts as an error voltage and produces magnetic flux. This magnetic flux is overcome by the level of the error signal on line 233, causing the electrically actuated valve 2
Air line 2 that passes through 44 and connects to air line 231
The flow of compressed air from 88 is regulated by valve 244.

Air line 288 supplies compressed air to a pressure of 40 to 45 psj (lb/sj) set by a pressure regulator (not shown).
(inch 2)). This pressure regulator is 70
It is coupled to an air line 243 carrying compressed air delivered from a pressure regulator 187 at a pressure of ~80 ps i. The regulated air flow on air line 231 is coupled by a jeweled orifice 247 to a consumption line 245 that leads to the atmosphere. Orifice 247 is essentially a cavity with a controlled leak rate. The jeweled orifice converts the regulated flow into a corresponding regulated pressure by controlling the leakage of compressed air through a boat of constant diameter relative to atmospheric pressure. Any cavity whose leak rate can be controlled can be used in place of a jeweled orifice. The relationship between flow rate and corresponding pressure is substantially linear.

The error signal generation circuit and feedback system described herein operate directly. The elements within the dashed box 249 of FIG. 9 constitute the linear pressure control regulating valve system 249 of FIG. 8B.

The MVS console has several modes of operation.

One of these modes is a proportional cutting mode for scissor operation. It is this mode that is used to inject viscous liquids.

This injection connects the same type of adapter conduit shown at 34 in FIG. 3 to the pneumatic outlet line 131 in FIG.
1 is performed by combining with . Thereafter, in some embodiments, the user may use the front panel controls 46 shown in FIG. 8B.

To set the maximum flow rate for the current viscosity condition,
Set the desired maximum injection pressure (although this control serves two purposes and is not relevant here).

Also used to set the highest desired vacuum level for suction operations. ). At that time, the user sets the proportional cutting mode using the mode selection switch 160 on the front panel.

Software for implementing the proportional cutting mode is shown in flowchart form in FIG. 10 and is disclosed in U.S. Pat.
, No. 506, it is given as a binary number listed in hexadecimal format. This patent is early incorporated herein by reference. There is a mode selection software routine (not shown) that determines the mode of operation desired.

and to perform the selected mode of work.

Branch to the appropriate module or subroutine.

If the branch is to scissor proportional cutting mode, processing is directed to step 326 of FIG. In this mode air pressure is applied to the pneumatically driven syringe,
The pressure value applied to the syringe plunger is a substantially linear function of the percentage of full depression of the foot operated control.

In a preferred embodiment, the maximum pressure that can be applied is 20 ps.
It is i. In other embodiments, a user may set the desired maximum pressure via a front panel control. The first step 328 initializes the interlaced data and prints the mode name on the front panel display. The only interlabd used in the preferred embodiment is interlabd 1. This interloved.

Amplify the software timer that controls how often the display is updated.

Next, step 330 to change the mode.

Front panel switches are checked. The front panel cassette eject switch is then checked to determine whether the cassette should be ejected and whether it is safe to do so. Also, this step.

A check is made to determine if a cassette is nearby by reading the proximity switch 64.

Then, if a cassette is nearby, it issues the appropriate command to pull out the cassette inside.

In step 332, input air pressure is checked by reading an input air pressure sensor (not shown) to ensure that there is sufficient air pressure.

The main step in this mode is step 334, which reads the foot actuation control position sensor to determine the desired value of air pressure to be generated on line 231 of FIG. 9 and the value applied to the syringe. The position sensor is read through the ^/D converter 144 as described above.

Next, in step 336, the microprocessor.

By multiplying the total displacement of the footswitch position sensor relative to full scale by 20psi and multiplying it by a constant,
Calculate the desired air pressure. This result is sent to D/A converter 140 where it is converted to an analog "desired pressure" signal on line 223. This signal controls linear electrically actuated valve 244 via the circuit described above;
Generates the desired air pressure to be output.

Although the invention has been described based on the preferred and alternative embodiments disclosed herein.

Those skilled in the art will appreciate many modifications that may be made without departing from the spirit and scope of the invention. All such modifications are intended to be included within the scope of the claims appended hereto.

(Leaving space below) - Rainbow - Lesson 91 ■υ Mouth W Team Figure 1 is an anatomical diagram of the eye to show the relationship between the retina and choroid and the method of injecting fluid between the anterior retinal membrane and the retina. Figure 2 Figure 3 shows the structure of the eye and anterior retinal membrane after injection of the viscous liquid surrounding the nail attachment point; Figure 3 is a perspective view of the device of the invention; Figure 4 shows the injection syringe and the connection connecting the syringe to the pneumatic hose. FIG. 5 is a cross-sectional view of the threaded bezel ring and threaded adapter used to attach the syringe to the pneumatic hose; FIGS. 6A and 6B are the threaded adapters of FIG. FIGS. 7A and 7B are end views and cross-sectional views of a threaded bezel ring for use with a pneumatic adapter; FIGS.
Figure B shows M used to perform continuous, linear mode injection.
VS console block diagram, Figure 9 is MVS
Console pressure analog circuit block diagram, 1st
Figure 0 is a flowchart of the software implementing the proportional cutting mode of the MVS console used to generate the pressure used in the continuous, linear mode of viscous liquid injection operation.

10... Retina, 12... Choroid, 14... Sclera,
16... Lens, 18... Anterior retinal membrane, 20.22
...Nail, 24...Membrane, 26...Needle, 28.3
0... Air bubble, 32... (Air pressure/vacuum) control unit, 34... Air pressure output 36...
・Air filter.

38...Syringe, 40...Piston, 42...Cavity part.

44... Air pressure gauge, 46... Air pressure regulator control, 48... Power on/off switch.

50...Mode control switch 7, 52...
Foot pedal control, 54... Time control, 56... Vacuum control, 58... Vacuum pressure gauge, 60... Pneumatic hose, 62... Flange, 64... Syringe holder, 66... Lock-in mechanism, 70...Cover/handle, 72...Protrusion, 74
...internal passage.

76...Syringe main body extension part, 77...Second passage,
78... Pneumatic tube engagement protrusion, 80... Rib, 82.94... Groove, 84... Bezel ring, 86
... Threaded part, 88 ... Aperture, 90 ... Surface, 92 ... Internal passage, 96.98 ... L-shaped groove,
100...wall.

that's all

Claims (19)

[Claims] 1. A device for injecting a viscous material into a body, the device comprising: a pneumatic output for generating an air pressure having predetermined characteristics at the output; a pneumatic hose coupled to the pneumatic output; a sterile filter for filtering gas flowing through the pneumatic hose; and a syringe having a sharp hollow needle, the syringe being coupled to the sterile filter to receive the filtered gas flow; A viscous material injection device having a material to be injected within a passageway formed by a syringe piston and the hollow needle. 2. The syringe has first and second ends and the first and second ends.
a hollow body with at least two flanges protruding from a location between the ends of the hollow needle;
the filter and the syringe are connected to each other by a coupler, the coupler being attached to an end of the hollow body for fluid communication between the filter and the inner cavity of the hollow body; It has 3 sections,
and the second section has a hollow passage between the at least two flanges and the first end for accommodating the protruding portion of the syringe, and the second section has a hollow passageway for accommodating the protruding portion of the syringe. a sealing means for forming a pneumatic seal between the projecting body portion and the second section, the second section bringing the at least two projecting flanges into intimate contact with the syringe body; and wherein the third section has means for forming a pneumatic coupling for receiving the filtered gas flow from the filter. The device described. 3. 2. A HEALON material within the passageway of the syringe and between the piston and the hollow needle.
The device described in. 4. 4. The apparatus of claim 3, wherein the filter is an in-line filter placed within the pneumatic hose. 5. The means for generating air pressure is an EFD of Ea.
st Providence, Rhode Island
3. The apparatus of claim 2, which is a Model 1000XL glue injection apparatus manufactured by d. 6. a foot-operated control coupled to said means for generating air pressure, said means for generating air pressure having means for applying a selectable air pressure level to said piston of said syringe, said air pressure level being coupled to said foot-operated control; 2. The device of claim 1, wherein the device is a linear function of a percentage of full scale depression. 7. The glue injection device includes a footswitch control and means for setting an air pulse time, the glue injection device further comprising a footswitch control and a means for setting an air pulse time, and further includes a step for applying a selected programmable air pressure level to the syringe while the footswitch control is actuated. 1 and having a selected programmable air pressure peak and a pulse duration set by the duration setting means.
6. Means for implementing a second mode in which the air pressure is applied to the syringe upon the first depression of the footswitch and ceases upon expiration of a selected time interval. Device. 8. 8. The apparatus of claim 7, wherein said glue injection device includes means for generating a selected level of vacuum and applying said selected vacuum level after application of air pressure in either mode. 9. A device for injecting a viscous material into the body, the device having a control transducer, a pneumatic peak control, and a time interval control, and having a programmable pneumatic pressure level set by operation of the pneumatic peak control when a control switch is actuated. a first mode in which the application stops when the application to the output section starts and the control switch stops operating, and the air pressure peak selected by the operation of the air pressure control and the duration set by the operation of the control. a second mode in which a pneumatic pulse having a pulse duration of 0.001 to 0.05 is applied to the output upon actuation of the control switch, and in which the application ceases at the expiration of a time interval set by a time interval control; a pneumatic means for generating pneumatic pressure in the output section in any of the modes; a pneumatic tube coupled to the output section; and a filter output section pneumatically coupled to the output section via the pneumatic tube. a sterile filter; and a sterile syringe pneumatically coupled to the filter output, the syringe having a passageway formed in the syringe by a sterile piston, the passageway being connected to at least a first and a first syringe by the piston. the syringe is divided into two separate passageways, and the syringe has a sterile hollow needle fluidly connected to the first passageway, and the filter output is fluidly connected to the second passageway. , wherein the syringe stores a viscous material within the first passageway. 10. 10. The device of claim 9, wherein the viscous material is HEALON sodium hyaluronate. 11. 10. The method of claim 9, wherein said pneumatic means further comprises vacuum means for generating a programmable level of vacuum and automatically applying said vacuum to said second passageway of said syringe upon termination of application of pneumatic pressure to said syringe. The device described. 12. An apparatus for injecting a viscous material into a body, the apparatus comprising: a control transducer; the control transducer generating an air pressure at an output that is a linear function of the position of the control transducer; a sterile filter pneumatically coupled to the output via the pneumatic tube and having a filter output; and a sterile syringe pneumatically coupled to the filter output; has a passageway formed in the syringe by a sterile piston, the passageway being divided by the piston into at least a first and a second separated passageway, and the syringe having a passageway formed in the syringe by a sterile piston; A viscous material injection device having a sterile hollow needle fluidly connected to the second passageway, the filter output fluidly connected to the second passageway, and the syringe storing the viscous material within the first passageway. 13. pneumatic means having a maximum pressure control, said pneumatic means comprising means for reading the position of the maximum pressure control and using the maximum pressure set by said position as an upper limit in an interpolation calculation, said control transducer; converts a full scale depression of the control transducer into a pressure set by the maximum pressure control, and below a full scale depression of the control transducer, is substantially proportional to a pressure between atmospheric pressure and the maximum pressure. 13. The apparatus of claim 12, wherein the air pressure is generated as a linear function of the position of the control transducer to be scaled. 14. A method of injecting viscous material into the body using a glue injection unit with a pressure control for setting the maximum air pressure at the pneumatic output, the method comprising: a hollow needle and a sharp tip to hold the viscous material to be injected; pneumatically coupling a syringe with a syringe to the pneumatic output; applying pneumatic pressure to the syringe and testing the flow rate of the viscous material exiting the hollow needle; the flow rate being suitable; adjusting the air pressure until the tip of the needle is inserted into the body at the location where the viscous material is to be injected; and applying the selected air pressure until a sufficient amount of the viscous material is injected. A viscous material injection method that includes a process. 15. a variable pressure control, a variable time control, a mode selection switch for selecting between continuous mode and one shot mode, a pressure control switch, and a pneumatic output coupled to a syringe having a sharp tipped needle. A method for injecting a viscous material into the body, using a pneumatic unit in which the syringe stores the material to be injected, the method of injecting a viscous material into the body by operating the pressure control switch and applying air pressure to the output part. observing the flow rate of the material from the tip of the syringe during sample injection and setting the pressure by operating the variable pressure control until the desired flow rate is obtained; and the mode selection switch. select the one-shot mode by operating the one-shot mode, set the time interval of the air pressure pulses generated during the one-shot mode, and press the pressure control switch as many times as necessary to generate a number of the air pressure pulses at the output section. performing a sample injection outside the body by operating the variable time control to adjust the pulse time until the appropriate pulse time is obtained; and selecting the desired mode by operating the mode selection switch. and if the continuous mode is selected, the pressure control switch is operated until the needle of the syringe is placed at the location where the inflow of the material is to be made and the desired amount of the material is injected. , then terminating the operation of the pressure control switch; repeating the process at other locations in the body deemed necessary; and, if the one-shot mode is selected, terminating the operation of the pressure control switch at the location on the body where the injection is to be made; A method for injecting a viscous material, comprising the steps of placing the needle tip and operating the pressure control switch, and repeating the steps at other positions as necessary. 16. The pressure generator includes a vacuum generator that applies a selected degree of vacuum to the syringe following application of air pressure, and a variable vacuum control, and the step of performing sample injection outside the body includes 16. The method of claim 15, further comprising the substep of operating the variable vacuum control until a sufficient level of vacuum is applied to prevent spilling of the last drop of material from the needle tip. 17. The location at which the material is injected is between the membrane of the eye and the retina, and is necessary to separate the membrane from the retina and to separate and destroy all attachment points between the membrane and the retina. After injecting in sufficient locations, horizontally oriented intraocular scissors are applied through the viscous material to each unbroken attachment point to sever the attachment, followed by dissection of the membrane and any remaining adhesive. Claim 1 comprising the step of aspirating the viscous material from the eye.
6. The method described in 6. 18. A method for injecting a viscous material into the body, comprising a variable pressure control, a foot-operated pressure control switch, and a pneumatic output coupled to a syringe having a sharp tip, the syringe storing the material to be injected. operating the pressure control switch to apply air pressure to the output during sample injection outside the body;
observing the flow rate from the syringe and setting a desired maximum air pressure output pressure by manipulating the variable pressure control until the desired flow rate from the needle tip is obtained; placing the needle tip at a desired position, operating a foot-operated pressure control transducer to a selected percentage of full-scale depression, injecting viscous liquid and observing the result of the injection; A method for injecting viscous material comprising the steps of: operating the foot-operated pressure control transducer until sufficient viscous liquid is obtained; and repeating the steps at other locations as necessary. 19. The location at which the material is injected is between the membrane of the eye and the retina, and is necessary to separate the membrane from the retina and to separate and destroy all attachment points between the membrane and the retina. After injecting in sufficient locations, horizontally oriented intraocular scissors are applied through the viscous material to each unbroken attachment point to sever the attachment, followed by removal of the membrane and any remaining adhesive. Claim 1 comprising the step of aspirating the viscous material from the eye.
8. The method described in 8.